Lacunar Intervention Trial 1 (LACI-1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Phase II pilot randomised, factorial, short term dose escalation, open label, blinded intermediary endpoint trial, in two hospital centres in the UK, of tolerability and safety of cilostazol, isosorbide mononitrate, both or neither in patients with small vessel disease manifest as symptomatic small subcortical stroke.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients

NCT04991038

Stroke Stroke, Ischemic Stroke, Acute +2 more

WITHDRAWN NA

Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial

NCT06091332

Cavernous Malformations Intracerebral Hemorrhage Brainstem Stroke

RECRUITING PHASE2

Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies

NCT04400981

Ischemic Stroke

COMPLETED NA

Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke

NCT05743101

Acute Ischemic Stroke

NOT_YET_RECRUITING NA

Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

NCT06511089

Stroke, Acute Stroke, Ischemic Carotid Stenosis +2 more

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A quarter of all ischaemic strokes are lacunar (small vessel) in type, about 35000 per annum in the United Kingdom, and due to an intrinsic, non-atheromatous, non-cardioembolic perforating cerebral arteriolar disease. 'Small vessel disease' also affects the brain diffusely, causing up to 40% of dementias, alone or mixed with Alzheimer's disease, 350,000+ patients estimated currently in the United Kingdom. There is no proven treatment: conventional antiplatelet drugs may be ineffective or even hazardous, antihypertensive treatment and statins have been disappointing. The disease mechanism is poorly understood but endothelial dysfunction, blood-brain barrier failure and vessel stiffness appear to contribute to the pathogenesis. Promising data available for licensed drugs with relevant modes of action, cilostazol (\>6000 stroke patients in the Asia Pacific region) and isosorbide mononitrate (ISMN, widely used in cardiac disease) support their testing in small vessel disease. This trial will be a phase 2, randomised, dose-escalation, factorial trial to test short-term administration of cilostazol, Isosorbide Mononitrate, both, or neither, to provide data on patient tolerability of dose (including headache, dizziness), safety (including blood pressure, platelet function), provide mechanistic evidence of efficacy (cerebrovascular reactivity, arterial compliance), and to inform the design of a larger phase 2-3 trial. The trial will recruit 60 patients with small vessel disease, in two expert stroke centres (Edinburgh and Nottingham) where there are suitable patients, expert stroke centres, established trials infrastructures and neuroimaging and platelet testing expertise. The trial will also advance methods to stratify patients by small vessel disease burden in routine practise and data on intermediary mechanistic outcomes to assist in planning future trials testing novel agents for either stroke or dementia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Small Vessel Diseases Cognitive Impairment Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Isosorbide mononitrate 25mg bd

Group Type ACTIVE_COMPARATOR

isosorbide mononitrate

Intervention Type DRUG

slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis

Group 2

Cilostazol 100mg bd

Group Type ACTIVE_COMPARATOR

cilostazol

Intervention Type DRUG

phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects

Group 3

Isosorbide mononitrate 25mg bd and cilostazol 100mg bd start immediately

Group Type ACTIVE_COMPARATOR

isosorbide mononitrate

Intervention Type DRUG

slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis

cilostazol

Intervention Type DRUG

phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects

Group 4

Isosorbide mononitrate 25mg bd and cilostazol 100mg bd delayed start

Group Type OTHER

isosorbide mononitrate

Intervention Type DRUG

slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis

cilostazol

Intervention Type DRUG

phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

isosorbide mononitrate

slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis

Intervention Type DRUG

cilostazol

phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Isotard pletal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mild symptomatic ischaemic stroke in the past four years compatible with a clinical lacunar stroke syndrome, with brain magnetic resonance imaging or computed tomography scanning that is compatible with a symptomatic small subcortical (lacunar) infarct, or if no recent relevant infarct is visible, that excluded other cause for symptoms
* Age \> 35 years
* Independent in activities of daily living (modified Rankin ≤2)
* Able to give consent themselves

Exclusion Criteria

* Other significant active neurological illness present since suffering stroke (eg seizures, multiple sclerosis, brain tumour)
* Age \< 35
* Montreal Cognitive Assessment score \<26
* Requiring assistance with activities of daily living (Modified Rankin ≥3)
* Active cardiac disease (atrial fibrillation, myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
* Carotid stenosis \> 50% in the symptomatic artery territory requiring carotid endarterectomy (prior and apparently successful carotid endarterectomy is not an exclusion criterion)
* Definite indication for, or definite contraindication to either trial drug
* Unable to swallow
* Bleeding tendency (platelets\<100, taking anticoagulant medication)
* Unlikely to comply with trial medication
* Planned surgery during the trial period
* History of intracranial haemorrhage (subdural haematoma, subarachnoid haemorrhage, intracerebral haemorrhage, but not asymptomatic haemorrhagic transformation of infarction)
* Other life threatening illness
* History of drug overdose or attempted suicide or significant active mental illness
* Pregnancy
* If recruited in Edinburgh and participating in cerebrovascular reactivity arm of trial: active respiratory illness (such as moderate to severe asthma or chronic obstructive airways disease), unable to tolerate magnetic resonance imaging or unable to lie flat

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No